Clinical Trials Directory

Trials / Completed

CompletedNCT02062450

Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup

Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup

Status
Completed
Phase
—
Study type
Observational
Enrollment
379 (actual)
Sponsor
Stryker Trauma and Extremities · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

Detailed description

The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed

Conditions

Interventions

TypeNameDescription
DEVICEPrimary surgery with Dual Mobility CupHip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
DEVICERevision surgery with Dual Mobility CupHip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Timeline

Start date
2013-05-01
Primary completion
2013-11-01
Completion
2013-12-01
First posted
2014-02-13
Last updated
2017-05-04
Results posted
2016-05-16

Source: ClinicalTrials.gov record NCT02062450. Inclusion in this directory is not an endorsement.